UMIN-CTR Clinical Trial

Basic information
Public title	Comparison of decompression, decompression plus fusion, and decompression plus stabilization for degenerative spondylolisthesis: a prospective, randomized study
Acronym	A prospective randomized study of surgical treatment for degenerative spondylolisthesis
Scientific Title	Comparison of decompression, decompression plus fusion, and decompression plus stabilization for degenerative spondylolisthesis: a prospective, randomized study
Scientific Title:Acronym	A prospective randomized study of surgical treatment for degenerative spondylolisthesis
Region	Japan

Condition
Condition	Degenerative spondylolisthesis
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The selection of surgical procedure for lumbar spinal stenosis due to degenerative spondylolisthesis is still under debate. The purpose of this study is to prospectively assess the clinical results of decompression alone, decompression plus fusion, and decompression plus stabilization for degenerative spondylolisthesis.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Clinical outcomes were evaluated by JOA score, VAS, and SF-36 before surgery, at 1 year and 5, 10 years after surgery .
Key secondary outcomes	Amount of bleeding, operation time, and radiological evaluations etc were evaluated

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Decompression
Interventions/Control_2	Decompression and fusion
Interventions/Control_3	Decompression and stabilization
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	75 years-old >=
Gender	Male and Female
Key inclusion criteria	One level lumbar spinal stenosis due to degenerative spondylolisthesis
Key exclusion criteria	Previous history of lumbar spinal operation Multilevel stenosis Foraminal stenosis
Target sample size	84

Research contact person
Name of lead principal investigator	1st name Middle name Last name Hiroyuki Inose
Organization	Tokyo Medical and Dental University
Division name	Department of Orthopedic Surgery
Zip code
Address	1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL	03-5803-5279
Email	inose.orth@tmd.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Hiroyuki Inose
Organization	Tokyo Medical and Dental University
Division name	Department of Orthopedic Surgery
Zip code
Address	1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL	03-5803-5279
Homepage URL
Email	inose.orth@tmd.ac.jp

Sponsor
Institute	Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization	N/A
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2017 Year 07 Month 06 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2003 Year 05 Month 30 Day
Date of IRB
Anticipated trial start date	2003 Year 09 Month 30 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 07 Month 06 Day
Last modified on	2021 Year 08 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032185